Menu
Apply
Menu
MENU

Compliance

A Long-Standing Commitment to Compliance

A strong commitment to compliance has been a hallmark of the Co-Pay Relief Program (CPR) since its inception in early 2004. As the holder of the second opinion issued by the Office of Inspector General (OIG) to a charitable patient assistance program, we have always understood our obligation to operate our program with the highest degree of ethical decision making, ensuring all policies, procedures and practices are designed and implemented in a manner that comports with both the spirit and intent of the OIG guidance received by the foundation over the past two decades.

We are proud of the manner in which our organization maintains safeguards to ensure that we operate our program, independently, free from donor influence, and in compliance with the guidance provided by the OIG in our opinion, # 04-15 issued to PAF in 2004 and modified in 2008 and 2015, as well as the Special Advisory Bulletins issued in 2005 and 2014, including a best in class organization wide compliance program.

PAF fosters an environment, both internally and externally, that is focused on our compliance with the applicable federal and state fraud and abuse laws including but not limited to, the anti-kickback statute and the civil monetary penalties law.

Compliance

Compliance Program Leadership

For nearly two decades, PAF has engaged the services of Arent Fox, LLP, Washington, DC, as its regulatory counsel. Arent Fox are experts in regulatory affairs, specializing in compliance programs relative to patient assistance programs and lead the development, implementation and ongoing management of PAF’s organizational compliance program, as well as serves as its Compliance Counsel. The Compliance Program is based on the seven elements of an effective compliance program set forth in the Federal Sentencing Guidelines Manual and applicable Department of Health and Human Services Office of Inspector General (“OIG”) guidance and is designed to assist PAF in preventing, detecting, and responding to illegal, improper, and unethical conduct, serving as a procedural framework for enhancing and monitoring compliance with applicable law, regulation, the PAF Code of Conduct and PAF’s policies and procedures.

Stephanie Trunk, Esq.
Stephanie Trunk, Esq.
Partner
Arent Fox, LLP
PAF Compliance Counsel
STEPHANIE TRUNK is a partner in and the co-practice group leader of the Health Law Group at Arent Fox LLP in Washington, D.C. Among other things, Ms. Trunk has significant experience structuring patient assistance programs for and providing ongoing counseling to both independent charitable foundations and pharmaceutical manufacturers to ensure compliance with applicable fraud and abuse laws, regulations and governing Office of Inspector General Advisory Opinions and guidance related to such patient assistance programs. In her practice, Ms. Trunk routinely counsels clients on reimbursement, fraud and abuse and regulatory compliance related to pharmaceuticals and devices for manufacturers, entities in the supply chain and other stakeholders. She received a J.D. with Highest Honors from the George Washington University Law School in 2003, also holds has a graduate certificate in health management from the George Washington University School of Public Health (2003) and received a B.S. in Accounting Summa Cum Laude from the University of Maryland in 1997. Ms. Trunk serves in the formal role of Compliance Counsel for PAF.

Compliance Program Materials

PAF Compliance Program Overview
Code of Conduct

Office of Inspector General
Advisory Opinion

OIG Opinion #04-15
2008 OIG Opinion #04-15 Modification
2014 OIG Opinion #04-15 Modification

Independent Auditor’s Reports

2020 Auditor’s Report
2019 Auditor’s Report
2018 Auditor’s Report
2017 Auditor’s Report
2016 Auditor’s Report
2015 Auditor’s Report
2014 Auditor’s Report
2013 Auditor’s Report
2012 Auditor’s Report

Compliance Counsel Contact Information

Stephanie Trunk
(202) 857-6171
Confidential Compliance Hotline:
1-202-480-2291

Confidential Compliance Form







" …to my great relief “Co-Pay Relief” covered the copay. This help has given back to me the hope of many years to come. All the people I have spoken to have handled my case with dignity and respect … I am grateful that CPR is helping me stay alive. "

Betty | Pulmonary Fibrosis

" … I live on a fixed income and need to spend a big portion of my income for medicine in order to maintain my health … I tried very hard to control my budget for medicine. Due to high cost of living now I have a hard time supporting myself … thanks to the great PAF I was approved to have a fund to help … then I felt the cord holding my neck tightly being released a lot. PAF is helping poor patients, including me. PAF is doing an excellent job with professionalism … PAF changed my life for the better, thank you. "

Shing | Hepatitis B

" Thank you for the co-pay assistance. I appreciate it! "

Yen | Hepatitis C

" Without this assistance, I would have to choose what to go without to ensure that I had money for my treatment. Thank you! "

Roberto | Prostate Cancer

" How can anyone just say “thank you” when you have your life saved…that’s exactly what your organization did for me. There would have been no way I could pay for the cost of my medication… "

Dominica | Hepatitis B

" With your help I am able to purchase the drugs that will help me finally beat this illness and be rid of it for good. Thank you so much. "

Stan | Hepatitis C
Apply